The BEAUTIFUL Study: Effects of Ivabradine in Patients With Stable Coronary Artery Disease and Left Ventricular Systolic Dysfunction
Effects of Ivabradine on Cardiovascular Events in Patients With Stable Coronary Artery Disease and Left Ventricular Systolic Dysfunction. A Three-year Randomised Double-blind Placebo-controlled International Multicentre Study.
1 other identifier
interventional
10,917
1 country
1
Brief Summary
The aim of this study is to test whether ivabradine is able to reduce cardiovascular events when given to patients with coronary artery disease and impaired heart function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2004
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 31, 2005
CompletedFirst Posted
Study publicly available on registry
September 2, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2008
CompletedResults Posted
Study results publicly available
June 25, 2015
CompletedApril 12, 2018
March 1, 2018
3.2 years
August 31, 2005
May 13, 2015
March 13, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Primary Composite Endpoint
First event among cardiovascular death, hospitalisation for acute myocardial infarction (fatal or not), or hospitalisation for new onset or worsening heart failure (fatal or not).
From the date of randomisation to the date of the first occurrence of the first event, up to 3 years.
Secondary Outcomes (12)
Cardiovascular Death
From the date of randomisation to death, up to 3 years.
Hospitalisation for Acute Myocardial Infarction
From the date of randomisation to the date of first occurrence of the event, up to 3 years.
Hospitalisation for New Onset or Worsening Heart Failure
From the date of randomisation to the date of first occurrence of the event, up to 3 years.
All-cause of Mortality
From the date of randomisation to death, up to 3 years.
Coronary Artery Disease Death
From the date of randomisation to death, up to 3 years.
- +7 more secondary outcomes
Study Arms (2)
Ivabradine
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Coronary artery disease
- Left ventricular systolic dysfunction
- Sinus rhythm: heart rate (HR) \>= 60 beats per minute (bpm)
You may not qualify if:
- Unstable cardiovascular condition
- Severe congestive heart failure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Royal Brompton National Heart and Lung Hospital
London, SW3 6NP, United Kingdom
Related Publications (1)
Fox K, Ford I, Steg PG, Tendera M, Ferrari R; BEAUTIFUL Investigators. Ivabradine for patients with stable coronary artery disease and left-ventricular systolic dysfunction (BEAUTIFUL): a randomised, double-blind, placebo-controlled trial. Lancet. 2008 Sep 6;372(9641):807-16. doi: 10.1016/S0140-6736(08)61170-8. Epub 2008 Aug 29.
PMID: 18757088RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The section Other Adverse Events (Not including serious) has been completed by the sponsor to include only the Non Serious Adverse Events emergent on treatment during the study.
Results Point of Contact
- Title
- Therapeutic Innovation Pole
- Organization
- Institut de Recherches Internationales Servier (I.R.I.S.)
Study Officials
- STUDY CHAIR
Kim Fox, MD
Royal Brompton National Heart and Lung Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 31, 2005
First Posted
September 2, 2005
Study Start
December 1, 2004
Primary Completion
February 1, 2008
Study Completion
February 1, 2008
Last Updated
April 12, 2018
Results First Posted
June 25, 2015
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Time Frame
- After Marketing Authorisation in EEA or US if the study is used for the approval.
- Access Criteria
- Researchers should register on Servier Data Portal and fill in the research proposal form. This form in four parts should be fully documented. The Research Proposal Form will not be reviewed until all mandatory fields are completed.
Researchers can ask for a study protocol, patient-level and/or study-level clinical trial data including clinical study reports (CSRs). They can ask all interventional clinical studies: * submitted for new medicines and new indications approved after 1 January 2014 in the European Economic Area (EEA) or the United States (US). * Where Servier or an affiliate are the Marketing Authorization Holders (MAH). The date of the first Marketing Authorization of the new medicine (or the new indication) in one of the EEA Member States will be considered within this scope.